MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN K-WIRE; PLATE, FIXATION, BONE

Catalog Number UNK_SEL

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "on 29.02.2024 an asnis screw of which the thread came loose.He was twisted into a metatarsal.Another k-wire crossed but we doubt if it was in the way.".

Manufacturer Narrative

Please note corrections to sections d1, d2a and d2b.The reported event could be confirmed based on the inspection performed.The catalog # and the lot # are not marked on such devices and were not communicated.Based on the device's dimensions (diameter approx.1.40 mm and length approx.150 mm) and the threaded tip, it could be identified as 702459 or 702459s.It is unknown if the device was released sterile or not, hence, the catalog could not be determined with accuracy.The screw was returned stuck around the k-wire.It was not deemed necessary to disassemble the devices, since it would not have given any further information.The tip of the k-wire is bent, close to the section were the threads of the screw are unraveled.There are no clear signs (such as scratches) that could indicate that the deformation results from the devices being in contact with another k-wire when inserting the screw.It was communicated that the patient suffers from diabetes and that the bone in question was soft, excluding bone hardness as the root cause of the deformation.This could be confirmed by the x-ray received.Note: it was not possible to determine with the x-ray if the devices crossed another k-wire during the insertion.Based on investigation, the root cause of the reported event was attributed to an user related issue.The deformation of the devices is most probably a result of excessive bending and/or torsional load applied during insertion.As a reminder, the instructions for use clearly state: "do not bend the asnis iii implant, because it may reduce its fatigue strength and can cause failure under load [.] ¿ while rare, intra-operative breakage of instruments can occur.Instruments which have experienced excessive use or excessive force are susceptible to breakage.Instruments should be examined for wear or damage prior to surgery." a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "on (b)(6) 2024 an asnis screw of which the thread came loose.He was twisted into a metatarsal.Another k-wire crossed but we doubt if it was in the way." 26-mar-2024 - update "no permanent injury to the patient.We were able to remove the screw in its entirety and install a new one.".

• Brand Name: UNKNOWN K-WIRE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18981339
• MDR Text Key: 338631322
• Report Number: 0008031020-2024-00144
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/21/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1